Levothyrox, baclofen,… the drug Agency under fire

The national security Agency of medicines and health products (MSNA) has experienced a difficult year. Friday, September 8, dozens of people gathered in front of the national Assembly to request the abandonment of the new formula of the drug to the thyroid Levothyrox designed by the German laboratory Merck KGaA. A request made by the MSNA in 2012 in the laboratory to obtain “stability is more important to the content of active substance” of the treatment, and implementation last march. In August, the health authority recommended not to move to the old formula after taking the new.

But since their transition to the new formula, several hundreds of patients report that they suffer from dizziness, cramps, fatigue, loss of hair. The former magistrate Marie-Odile Bertella-Geffroy, who also uses this medicine,will become “legal council” of the French Association of patients of the thyroid (AFMT). She will introduce next week a complaint against the laboratory, but also against the French health authorities. A complaint followed that of the lawyer Anne-Catherine Colin-Chauley.

If the patients are on the front of the media scene, critics abound also in a part of the doctors. The Union of liberal physicians deplores a “communication by stealth of the public authorities” and denounced the fact to be put in the “first line” in the face of the patients. Or the Fédération des médecins de France (FMF) has denounced the decision of the MSNA during a press conference on 6 September . “There has been no consultation with the doctors !”, exclaims Jean-Paul Hamon. “We needed to better inform the population,” he says. Agnès Buzyn minister of Health, has come to recognize a “lack of information”. Following the controversy around the new formula of the Levothyrox, she announced the forthcoming establishment of a working group “to better inform patients and health professionals about the drugs.”

Controversy around the dose of baclofen

It must be said that these communication problems identified between health authority, patients and physicians are not new. Two other cases of the recommendations of the MSNA on medication, have particularly irritated the patients and physicians in 2017.

In July, the Agency has taken the decision to reduce drastically the threshold of the maximum dose of baclofen (300 mg to 80 mg), a molecule against addiction to alcohol in July, has led to the misunderstanding. The MSNA was based on a study conducted by the national health insurance Fund and the Inserm published at the beginning of the month of July and alerted on the risk of hospitalization and even death due to a use of the molecule at very high dose. But in a forum, medical experts from the addiction believe, that by lowering this dose, many patients are at risk of falling back into addiction, based on the testimonies of patients need. According to them, two-thirds of the patients treated in the centres addictologies would take more than 80 mg of the molecule. The FMF has denounced a decision “too early”.

The imbroglio of docetaxel

A few months earlier, the instructions given by the MAN on docetaxel – an anticancer agent aimed to avoid the risk of recurrence in breast cancer – have caused an imbroglio. On march 29, the Agency had, following an investigation, given the number of 48 dead in the twenty years following the taking of this molecule. But in June, the european Agency, however, has held that there was no “on-risk”. A statement that has pushed the MAN to reauthorize the use of this molecule. But during this period, doctors have had to adapt in emergency substitute docetaxel for paclitaxel, a molecule with similar effects, but with a different dosage. Some have mentioned a mess in the cancer services.

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